FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/103830 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Voice-related difficulties and their impact on self-image in individuals with head and neck cancer. 
Scientific Title of Study   A cross-sectional study to explore the association between Self Image and Vocal Burden among Head and Neck Cancer patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SANGEETHA U M 
Designation  Junior Research Fellow 
Affiliation  Kasturba Medical College, MAHE 
Address  Research Cell, Department of Psychiatry, Kasturba Medical College, MAHE, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9902864810  
Fax    
Email  sum@georgeinstitute.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Samir Kumar Praharaj 
Designation  Professor and Unit Head 
Affiliation  Kasturba Medical College, MAHE 
Address  Department of Psychiatry, Kasturba Medical College, MAHE, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8971026304  
Fax    
Email  samir.kp@manipal.edu  
 
Details of Contact Person
Public Query  
Name  SANGEETHA U M 
Designation  Junior Research Fellow 
Affiliation  Kasturba Medical College, MAHE 
Address  Research cell, Department of Psychiatry, Kasturba Medical College, MAHE, Madhav Nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9902864810  
Fax    
Email  sum@georgeinstitute.org.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sangeetha U M 
Address  Kasturba Medical College, MAHE, Madhav Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sangeetha U M  Kasturba Medical College  Research cell, Department of Psychiatry, Kasturba Medical College, Manipal, Madhav Nagar, Karnataka 576104
Udupi
KARNATAKA 		 9902864810

sangeetha.kmcmpl2025@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients undergoing curative intent treatment for Head and Neck Cancer in Kasturba Medical College, Manipal and should be able to read and writer either Kannada or English.  
 
ExclusionCriteria 
Details  Patients with a known history of:
syndromal psychiatric disorders
sensory impairment (visual/auditory)
physical disabilities
epilepsy or other brain impairments
neurological conditions
dementia and Alzheimer 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between Self Image and Vocal Burden  NIL 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Head and neck cancer patients face body image issues and emotional distress, largely due to visible changes and loss of function caused by their illness and treatment. Although past research has shown how disfigurement affects body-image, the specific impact of vocal difficulties and related impairment in self-image hasn’t been explored enough. Since voice plays a key role in communication and social interactions, problems with vocal function might uniquely affect how patients see themselves and their overall mental wellbeing. Exploring the connection between vocal burden and self-image could fill this important gap and help improve patient care and quality of life. Therefor the aim of the study is to examine the relationship between Vocal Burden and self-image in patients with head and neck cancer. Permissions and Institutional Ethics Committee’s approval will be obtained before collecting the data. All Head and Neck Cancer patients reporting to the respective units (Medical-Oncology/Radiation-Oncology/Head and Neck surgery) and are currently on curative intent treatment will be approached for the study. The sample will be recruited using convenience sampling method. Data will be collected from participants after the informed consent is signed by them with assurance of confidentiality and withdrawal rights. The recruited participants will then be assessed using the Distress Thermometer, Voice Fatigue Handicap Questionnaire and Self Image Scale. The data collection will take approximately 30 minutes.  
Close